Protocol Packets SRC and IRB Reviews

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Sabina Wilson
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1 Protocol Packets SRC and IRB Reviews The Intel International Science and Engineering Fair (ISEF) established a protocol paperwork packet that assists student scientists, their adult sponsors and the mentors associated with them adhere to legal experimentation standards and to assure that the experimenters were not putting themselves and others in danger. - Every project will need a protocol packet when registering for the Regional Fair, whether they are preapproved or not. - Every project will require a Checklist (1), a 1A, and a 1B form along with the Research Plan. - Pre-Approval protocols will require additional forms (Form 6A for Potentially Hazardous Biological Agents (PHBA s), 6B for cell tissues, Form 4 and a Sample of Informed Consent for Humans, 5A and 5B for Animals/Vertebrates not human. - The Qualified Scientist (2) is generally required for studies to be performed in a lab, if they are BioSafety Level 2 projects. BSL-1 projects are traditionally overseen by a Designated Supervisor, in high school labs. - Pre-Approval Protocols should be resubmitted at the Regional Registration with the abstracts, a conclusion statement, and a Form 7 and 1C as applicable. Changes to the procedure portion of the Research Plan should be minimal. - The protocols of nearly all types should have the following: - Regional Office Keeps the Originals - Scanned copy of paperwork into computer, to upload for ISEF, if the project makes it to Internationals. - Scanned copy for State Science Fair, plus hard copy for State Science Fair. - Scanned copy sent to the Sponsor/Director of those students. (In the larger districts, it can be sent to the Director of that larger fair).

2 - The protocol packets after the Regional Fair, will be passed on to the State Fair with the appropriate Regional Fair signatures from the SRC or Director on them as needed. - The protocol packets should be kept in some copy form, either hard or scanned copy for 7 years and can be shredded a year after the student(s) graduate. The following pages of protocol are for a project that was selected to attend Internationals in It was a team project, that was also a phase 3, with a PHBA element therefore needing pre-approval. An addendum had to be added to the Procedure after the Regional fair because an additional test was added, but it didn t need pre-approval and didn t change the pre-approved portion of the project. Many projects will now have multiple testing aspects to them, of which the SRC is asked to determine which is applicable to Pre-Approval and then post approval. Additional forms will also be reviewed for informational purposes that are not reviewed for this example project, at the end of the main review. Some protocol packets will be upwards of 40 pages long, some will simply be around 7, depending on the complexity of the project, the number of phases of the project, and how many approvals are needed for the project.

Checklist (1) Needed for all Projects Student s names, this is one area where you can see how many students are on the team. If it is one name, it is an individual project.

3 Checklist (1) Needed for all Projects Student s names, this is one area where you can see how many students are on the team. If it is one name, it is an individual project. Boxes 1, 2 & 3 will need to be checked off for every project. Box 4 will need to be checked off for all pre-approval protocols, if they are dealing with humans, animals, and PHBA s. Item 5 needs to have the first four boxes checked off for all projects, projects where the student worked at a laboratory or a site that was not their school, will need a 1C form, and students who are doing a continutation/phase project will need a form 7. These two forms are not needed until after experimentation is done, meaning that these forms will be resubmitted if the project makes it to Regionals. These forms will be submitted along with the regional registration form. <- This is a redundant check box area but depending on what is being used, it needs to be checked again. <- Sponsor s printed name, here will also be the sponsor s contact information. The dates are moderately important, they all need to be before experimentation starts on both pre-approval and post approval protocols.

Student Checklist (1A) Needed for all projects. The team leader is theoretically filling out these forms, so their information is the primary one that will be there.

4 Student Checklist (1A) Needed for all projects. The team leader is theoretically filling out these forms, so their information is the primary one that will be there. Traditionally, they go with the alphabetical by last name as the leader, but others will go by grade. If it is an individual project, the team member slots will be empty. If the project needs pre-approval, this will be checked, with a tentative start date. This will be around the same time as the estimated SRC approval date. The form 7 and continuation project may be filled out, but do not have to be submitted until after experimentation for the Regional Registration post approval stage. The Actual Start Date and End date on pre-approvals may be blank, and this form will have to be resubmitted at the time of Regional Registration. If there is any other place marked for experimentation than school, the name and address of non-school work sites need to be filled in. If it is a Research Institution, then the 1C will need to be filled out at the end of experimentation.

Research Plan/Project Summary All Projects (This is the one that is most uncomfortable for everybody) This form should not really appear in the packet, it is an instruction sheet for the attachment.

5 Research Plan/Project Summary All Projects (This is the one that is most uncomfortable for everybody) This form should not really appear in the packet, it is an instruction sheet for the attachment. Pre-approval packets will not have an abstract, post-approval will have it. Last year, they required a conclusion statement for all projects, this year, they removed that. All pre-approved protocols will require a Project Summary instead of just the Research Plan, with an indication of what was changed between approval and experimentation. This will replace the Research Plan in the pre-approvals, at Regionals. It is preferred that the Research Plan is typed. Projects dealing with humans should assure that any and all private or identifying information should be eliminated.

6 Research Plan/Project Summary - Rationale - Problem/Objec tives - Hypothesis(es) - Detailed Procedures - Procedure Rationale - Data Analysis - Bibliography

7 1B For all Projects Each student either individual or team has to fill out one of these forms, and these will be provided as an individual form. If there are three people on the team, there will be three 1B s in the packet. Theoretically the one that has to be filled out by the Local or Affiliated SRC is the Team Leaders, but it is advised that all 1B s be filled out for each member of the team. The dates should coincide near the Checklist 1 Sponsor s approval date. Before experimentation. The Regional SRC Chair should fill out the box on the left, unless there was a local fair SRC signed off on it on pre-approval. The Regional SRC Chair will sign off on this again, if the project makes it to the Regional Fair This will be signed at State for projects that make it to State

xxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx PHBA Form 6A- Pre-Approval Microorganisms Only This is this year s form, as it changed from the previous year.

8 xxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx PHBA Form 6A- Pre-Approval Microorganisms Only This is this year s form, as it changed from the previous year. <- Team Leader s name should be first, with other team members to follow. <- All projects should be BSL-1 or BSL-2, this is a self-evaluation of every lab to determine their eligibility. Most high school labs are BSL-1. Qualified Scientist or Designated Supervisor should have checked off the appropriate experimentation level, and checked off what BSLlevel the project is, and then sign off on it. xxxxxxxxxxxx xxxxxxxxxxxx Regional SRC will sign off here for Pre-Approval, this and the 1B signatures are the two most important signatures.

Continuation Projects Form 7 Projects that are Continuations, Not needed until after experimentation This form is used for projects that are seeing a continuation from previous years.

9 Continuation Projects Form 7 Projects that are Continuations, Not needed until after experimentation This form is used for projects that are seeing a continuation from previous years. Students in the project should compare previous years against this year s project, and the project should see at least a 40% differential from the previous projects in procedure and purpose. All students should sign this form, after experimentation and it should be submitted with the Regional form. Along with this will be the previous year s Abstract, Research Plan and 1A and for years previous to that, abstracts that are clearly marked with the year.

10 Qualified Scientist Form (2) Only When Applicable The Qualified Scientist Form is needed when the human participants, vertebrate animals, PHBA s and DEA- controlled substances go beyond BSL-1 labs, or could be considered too dangerous to not be overseen by a Qualified Scientist. The Qualified Scientist has the ability to hand over responsibility to a Designated Supervisor in these cases where there is low risk. The rest of the time the Designated Supervisor is used and the Qualified Scientist is not needed. This also qualifies in the case of 1C forms. These should really be taken into consideration when working with Humans and Vertebrate Animals as per suggestion of the ISEF SRC.

11 Regulated Research Form (1C) Some projects after experimentation This form should be filled out any time the student works in a regulated research institution. This includes hospitals, universities, professional labs, etc. Any place that is not home, school or field, requires this 1C. This is also recommended for tests not done with the student s presence, e.g. if samples are sent off to be processed.

12 Human Participants Form (4) and Informed Consent Sample There are two versions of this form. The full item, and the Expedited Review. The full one requires all three signatures, the Expedited Review only requires one. The ISEF s SRC position on this is, if you are doing a blind survey, where the participants are only providing an opinion on an invention or project, or its only the student involved with minimal risk, then it only needs one signature. If there is any other questions, or any question, then have the full IRB review. The actual informed consents are not warranted for submission, only the samples. The only people who should see the actual informed consents are the adult supervisor and the student, but they should have them in possession if there is any question from the SRC. Judges should not ask for these sheets. It is also a general good idea to have the student s parents or the adult volunteer sign off on one of these, but not present it with the project just for SRC purposes.

Vertebrate Animal Forms 5A and 5B Vertebrate Animals If its not human, but it has a backbone, these two forms are required, and the project requires a Veterinarian at the very least.

13 Vertebrate Animal Forms 5A and 5B Vertebrate Animals If its not human, but it has a backbone, these two forms are required, and the project requires a Veterinarian at the very least. This too, has a pre-approval signature on 5A. If the student is doing a decomposition project, the animal had to be put down by something else, the same applies to coke and liver, the meat had to be guaranteed to have been obtained from a reliable source, or professional hunter, not the student. If it has a backbone, it can t die for the project. Not a single animal can die for the project. It can be put down for other reasons, but not the project. If it dies, the experimenter has to start over or choose another project.

14 Final Notes - The final Protocol Paperwork will be the version going to the State Science Fair. - The final Protocol Paperwork will be the version going to ISEF for students who have qualified from the Regional. These students will still be able to compete at State. - If a project who placed for ISEF at Regionals gets bumped up as an ISEF competitor at State, then the Regional Director will have 12 days to bump up their representative (Alternate) and upload their final protocol paperwork scans. The paperwork for the previous one will remain in place and State will upload their official signatures. - The protocol paperwork will go to State from Regionals for State placers, and ISEF placers. Previously, they wanted both hard copy and scan, but it is unknown if they will still do that. - The SRC evaluation at Regionals and State is not absolute. If the SRC has a question about a project that they are absolutely not comfortable with, they have the ability to contact the SRC at ISEF for an answer at SRC@societyforscience.org and should get an answer within 2 days. This is available for adult sponsors to do as well. The ISEF qualifier protocols are examined with a fine tooth comb at ISEF by the SRC. If there is a question or a problem, the ISEF SRC will call the student in for a meeting with the Adult Sponsor, AND the Regional Representative to represent the original Regional SRC decision. This used to be considered a fate worse than death, but now, has become a lot more friendly. The ISEF SRC hates disqualifying people, and like to rectify situations, but they do want a Regional Representative present at the fair to defend any issues that come up with the paperwork. They also try to go through it and rectify the situations before the fair, if they can. This applies to project display and safety as well.

Roles and Responsibilities of Students and Adults

Roles and Responsibilities of Students and Adults 1) The Student Researcher(s) The student researcher is responsible for all aspects of the research project including enlisting the aid of any needed supervisory